The Ethics of Global Clinical Trials

By Dr. Russell Medford, Salutria Pharmaceuticals

Recent reports have raised concerns about how clinical trials are being performed in other countries, particularly in the developing world. Even prior to these reports, some have asserted that sponsors conduct clinical trials abroad to avoid red tape and avoid overly stringent and time consuming regulatory processes. However, research done by companies with the intent of seeking FDA approval and access to the U.S. market must still meet FDA standards regardless of where the research is conducted. FDA regulations require trial sponsors to undertake several quality assurance and audit activities, and failure to abide by these rules could delay or disqualify a product’s chances of getting marketing approval. Companies develop numerous processes to ensure compliance and protect patient safety, including:

Pharmacovigilance conducted by experts (oftentimes hundreds of individuals in one company) who collect, analyze, follow-up, and distribute safety-related information from new drug trials.

Regular sponsor monitoring of clinical trial sites to ensure quality, compliance, and safety of research participants.

Quality assurance units that audit operations associated with clinical research to ensure adherence of company personnel to regulations, guidelines, and internal and external procedures, policies, and programs.

Unethical clinical trials, however rare, tarnish the reputation of all researchers and their work. BIO members are deeply concerned about any instance of unethical clinical research, and take seriously the ethical issues involved in conducting overseas clinical trials. BIO has long supported responsible and ethical testing, protection of individual privacy and genetic information, and regulatory systems that best serve humanity and advance research into new treatments for patients, regardless of where research is conducted. Toward that end, BIO supports appropriate oversight of clinical trials and medical research, whether conducted in the U.S. or elsewhere in the world. Performing important research and protecting research subjects are mutually attainable goals, and decisions regarding whether and how to use medical products and technologies must always be made with profound respect for the rights of patients. Appropriate regulation of biotech should be solidly rooted in values such as autonomy, privacy, beneficence, social justice, and intellectual freedom. Encouraging and enabling innovation through a timely and consistent regulatory process will ultimately result in medical treatments and cures for some of the most devastating and life-threatening diseases.

I wondered if you could answer a question for me? In a conversation about comparator drug sourcing, a comment was made that comparator drugs are more readily available for purchase outside of the U.S. I know that within the U.S. drug distribution channels, most manufacturers are closely monitoring the distribution patterns and buyers for their drugs. Can an ex-US purchased drug be used as a comparator for a trial that will be submitted to the FDA for approval?